Analytical Support Associate - (East Hanover, NJ)
Responsible for the administration of the stability programs and authoring Annual Stability Reports for US marketed products. Stability Study Administration Responsibilities: Ensures that all batches due to be placed on stability are received, accurately initiated with regard to quantity of samples, appropriate storage conditions per protocol and accurate time point pull schedule Assumes responsibility to ensure the stability assessments associated with change controls are successfully implemented Ensures that stability related follow-up corrective actions are completed Writes stability protocols and stability reports Represents the stability group on cross functional teams as necessary Maintains the stability environmental chambers and ensures timely destruction of excess material associated with completed stability studies. Responds to chamber alarms during off-hours and weekends (i.e. assigned rotation; coordinates with teammates to ensure chamber alarms are acknowledged and resolved)
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From Get It, LLC - 1 month ago